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PEG 6000 - High-quality water-soluble lubricant and pharmaceutical excipient from India

1. General Introduction to PEG 6000

PEG 6000 (Polyethylene Glycol 6000 or Macrogol 6000) is a high-molecular-weight synthetic polymer, distinguished by its excellent water solubility, being in a more solid state compared to lower molecular weight PEGs. This substance possesses excellent chemical stability and high biological safety. It is extensively applied in the pharmaceutical industry, particularly as a water-soluble lubricant (ideal for effervescent tablets), plasticizer, solubilizer, and suppository base.

The raw material is manufactured by Nitika Pharmaceutical Specialities Pvt. Ltd. (India), one of the world's leading specialized excipient manufacturers with international GMP certification. Through advanced synthesis and purification processes, Nitika's PEG 6000 achieves optimal purity, strictly controls hazardous impurity indices, ensures absolute consistency across production batches, and fully complies with the most stringent global pharmacopeial standards.

2. PEG 6000 Material Information

  • Material Name: PEG 6000 / Polyethylene Glycol 6000 (Macrogol 6000)
  • Manufacturer: Nitika Pharmaceutical Specialities Pvt. Ltd.
  • Origin: India
  • Category: Pharmaceutical Excipients / Active Pharmaceutical Ingredient (API).
  • Function: Water-soluble lubricant, binder, plasticizer for film coating, solubilizer, and a base that increases the melting point for ointments and suppositories.
  • Chemical Composition: Polymer of ethylene oxide and water, general formula H(OCH2CH2)nOH (with the average n corresponding to a molecular weight of approximately 6000).
  • Form: Flakes or fine white crystalline powder, solid, odorless or with a faint characteristic odor.
  • Solubility: Very soluble in water (forming a clear solution), freely soluble in ethanol and chloroform, practically insoluble in ether and fatty oils.
  • Quality Standards: Complies with United States Pharmacopeia (USP), European Pharmacopoeia (EP), British Pharmacopoeia (BP), or Indian Pharmacopoeia (IP) standards.

The raw material is strictly controlled for:

  • Toxic Impurity Limits: Strict control of Ethylene Glycol and Diethylene Glycol (EG/DEG) levels to extremely low thresholds below international pharmacopeia limits, ensuring absolute safety during use.
  • Molecular Weight Range: Ensures a precise molecular weight distribution from 5400 - 6600 g/mol to maintain stable physicochemical properties and viscosity.
  • Heavy Metals and Microbial Limits: Meets strict microbiological standards for both oral and topical preparations.

3. Advantages of PEG 6000 from Nitika

  • Superior water-soluble lubricant: Unlike Magnesium Stearate (which is insoluble in water), PEG 6000 dissolves completely, making it the ideal lubricant for effervescent tablets or formulations requiring clear solutions.
  • High purity and absolute safety: Nitika's organic impurity (DEG, EG) control process is extremely rigorous, completely eliminating toxicity risks.
  • Excellent formulation properties: Possesses high thermal stability, good overall stability, and compatibility with most common active pharmaceutical ingredients. When used as a film-coating excipient, it makes the coating flexible, glossy, and effectively prevents cracking. In suppositories, it helps adjust and increase the melting point of the base.
  • Reasonable Cost - Stable Supply: Manufactured in India by Nitika, the product offers highly competitive pricing compared to European sources, providing an effective solution for manufacturing plants to optimize production costs.

4. Applications of PEG 6000

In Pharmaceuticals (Primary Applications)

  • Effervescent tablets: Acts as the number 1 water-soluble lubricant, ensuring a smooth tableting process without sticking to the punches and dies, and guaranteeing the tablet dissolves to form a crystal-clear solution without leaving any residue.
  • Excipient for tablets and capsules: Used as a dry binder or plasticizer in film coating formulations.
  • Suppositories and Ointments: Used as a co-component in water-soluble bases for rectal/vaginal suppositories, helping to increase hardness and adjust the melting point to suit storage conditions.
  • Laxatives: Can be used as an osmotic laxative API in certain specific formulations.

In Health Supplements

  • Vitamin effervescent products: Widely applied as a tableting excipient for effervescent tablets supplementing Vitamin C, Multivitamins, and electrolytes.
  • Solubilizer and dispersant: Helps increase solubility and improve the bioavailability of herbal extracts or poorly soluble active ingredients.

5. Commercial Products Using PEG 6000

6. Product Contact Information

For more information on the supply chain, PEG 6000 technical specifications, or to place an order, please contact us:

  • Consultation Hotline: +84 (0) 834 560 500
  • Email: director@biorichgroup.com
  • Website:www.biorichgroup.com
  • Sample/COA Request: Please contact us via email to request a sample and the latest Certificate of Analysis (COA) of the raw material from the manufacturer, Nitika Pharmaceutical Specialities Pvt. Ltd.

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